Hodgkin LymphomaPhase 2NICE-40NCT04981899
PET-Adapted Low-Dose Nivolumab With NICE-40 for Relapsed/Refractory Classical Hodgkin Lymphoma
A Phase 2 study testing Nivolumab, Ifosfamide and Carboplatin in people with Hodgkin Lymphoma, run by St. Petersburg State Pavlov Medical University at 5 sites in Russia.
Trial summary
Nivolumab is an anti-PD-1 antibody with high activity in patients with relapsed/refractory classical Hodgkin lymphoma (r/r cHL). A PET-adapted strategy using nivolumab with ICE added for patients without complete response has shown high response rates and favorable progression-free survival as a bridge to autologous… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Nivolumab, Ifosfamide and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 5 sitesRussia
- Study dates
- 1 Mar 2021to 15 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Histologically confirmed Hodgkins lymphoma
- Relapsed or refractory disease after the first line of treatment
- Age 18-70 years old
- Ejection fraction greater than 50%
- ECOG 0-2 status
- Signed informed consent
- No severe concurrent illness
Who cannot join
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign an informed consent
- Active or prior documented autoimmune disease requiring systemic treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Irkutsk Regional Cancer Center
Irkutsk
Irkutsk State Regional Children's Clinical Hospital
Irkutsk
Moscow Clinical Research Center Hospital 52 of the Moscow City Health Department
Moscow
St. Petersburg State Pavlov Medical University
Saint Petersburg, Northwestern Federal District, 197022
National Medicine Research Center of oncology named after N.N. Petrov
Saint Petersburg, Pesochny, 197758
About this study
Official title: Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
Nivolumab is an anti-PD-1 antibody with high activity in patients with relapsed/refractory classical Hodgkin lymphoma (r/r cHL). A PET-adapted strategy using nivolumab with ICE added for patients without complete response has shown high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, while allowing omission of salvage chemotherapy in a substantial proportion of patients. This study evaluates the safety and efficacy of a PET-adapted strategy using fixed-dose nivolumab 40 mg, with ifosfamide, carboplatin, and etoposide (NICE-40) administered to patients without complete response to nivolumab monotherapy.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Nivolumab, Ifosfamide, Carboplatin, Etoposide
- Keywords
- Nivolumab, Ifosfamide, Carboplatin, Etoposide
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.
IfosfamideDrug
5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
CarboplatinDrug
Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
EtoposideDrug
100 mg / m2 intravenously on 1-3 days of the NICE-40.
| Study group | Role | What they receive |
|---|---|---|
| Main arm | Experimental | Patients will receive 6 cycles of nivolumab at the fixed dose of 40 mg, with subsequent assessment of response by PET-CT. Patients with CR will proceed to ASCT.
Patients with <CR after nivolumab monotherapy will be treated with 2 cycles of a combination of nivolumab at the fixed dose 40 mg, ifosfamide, carboplatin and etoposide (NICE-40), with subsequent PET-CT assessment. Receives: Drug: Nivolumab; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria
Measured: 12 months
Secondary outcomes (6)
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Measured: 12 months
Duration of Response (DOR)
Measured: 24 months
Overall Survival (OS)
Measured: 24 months
Progression-Free Survival (PFS)
Measured: 24 months
Progression-Free Survival Rate (Post Autologous Transplant)
PFS is defined as the duration of time from start of transplant to time of progression or death, whichever occurs first.
Measured: 24 months
Overall Survival (Post Autologous Transplant)
OS is defined as the duration of time from start of transplant to time of death (due to any cause).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Mar 2021
- Primary completion1 May 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
- Investigators
- Alexander Kulagin, MD,PhD, Study director, RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981899
- Sponsor's protocol ID
- r/r cHL NICE-40
- Acronym
- NICE-40
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04981899
- Acronym / sponsor ID
- NICE-40 / r/r cHL NICE-40
- Conditions
- Hodgkin Lymphoma
- Keywords
- Nivolumab, Ifosfamide, Carboplatin, Etoposide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nivolumab is an anti-PD-1 antibody with high activity in patients with relapsed/refractory classical Hodgkin lymphoma (r/r cHL). A PET-adapted strategy using nivolumab with ICE added for patients without complete response has shown high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, while allowing omission of salvage chemotherapy in a substantial proportion of patients. This study evaluates the safety and efficacy of a PET-adapted strategy using fixed-dose nivolumab 40 mg, with ifosfamide, carboplatin, and etoposide (NICE-40) administered to patients without complete response to nivolumab monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main arm | Experimental | Drug: Nivolumab, Drug: Ifosfamide, Drug: Carboplatin, Drug: EtoposidePatients will receive 6 cycles of nivolumab at the fixed dose of 40 mg, with subsequent assessment of response by PET-CT. Patients with CR will proceed to ASCT. Patients with <CR after nivolumab monotherapy will be treated with 2 cycles of a combination of nivolumab at the fixed dose 40 mg, ifosfamide, carboplatin and etoposide (NICE-40), with subsequent PET-CT assessment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis: Histologically confirmed Hodgkins lymphoma
- Relapsed or refractory disease after the first line of treatment
- Age 18-70 years old
- Ejection fraction greater than 50%
- ECOG 0-2 status
Key exclusion criteria (7 listed)
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
- Karnofsky index <30%
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40. | Drug | Main arm |
| Ifosfamide5000 mg / m2, 24-hour infusion on day 2 of the NICE-40. | Drug | Main arm |
| CarboplatinOptimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40. | Drug | Main arm |
| Etoposide100 mg / m2 intravenously on 1-3 days of the NICE-40. | Drug | Main arm |
Primary outcome
Overall Response Rate (ORR)
Time frame: 12 months
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria
6 secondary outcomes
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Time frame: 12 months
Duration of Response (DOR)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Progression-Free Survival Rate (Post Autologous Transplant)
Time frame: 24 months
Overall Survival (Post Autologous Transplant)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Kulagin, MD,PhD study director
RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Ifosfamide and Carboplatin in people with Hodgkin Lymphoma, run by St. Petersburg State Pavlov Medical University at 5 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.